In short
Clinical trials are studying ICOTROKINRA in people with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. These studies look at how well it works and how safe it is in adults and adolescents with moderately to severely active disease. The trials also measure remission, response, and endoscopic outcomes.
Key points
- Clinical trials are studying ICOTROKINRA in two main inflammatory bowel diseases: ulcerative colitis and Crohn’s disease. The ulcerative colitis study includes adults and adolescents and is in Phase 3. The Crohn’s disease study is in Phase 4 and also includes Phase 2b and Phase 3 parts. These trials are looking at clinical remission, clinical response, and in Crohn’s disease, endoscopic response. Both studies focus on people with moderately to severely active disease.
Trial overview
These studies are testing ICOTROKINRA in people with inflammatory bowel disease, which is a group of long-term diseases that cause swelling and irritation in the digestive tract. The trial data show two authorised interventional studies, one in ulcerative colitis and one in Crohn’s disease.
An interventional study means the researchers give a study treatment and compare results with placebo or another study group. The main goal is to see whether ICOTROKINRA helps people reach clinical remission, clinical response, and other signs of improvement.
Ulcerative colitis study
The ulcerative colitis trial is titled Efficacy and Safety of Icotrokinra in Adult and Adolescent Participants with Moderately to Severely Active Ulcerative Colitis. It is a Phase 3 study with 882 participants and is currently authorised.
This study includes three parts: an adult induction study, an adult maintenance study, and an adolescent study. Induction means the first part of treatment, where researchers check whether the study treatment can bring symptoms under control. Maintenance means the later part, where researchers check whether the benefit can be kept over time.
The adult induction part compares ICOTROKINRA with placebo to see if it can induce clinical remission by Week 12. The adult maintenance part looks at whether remission can be maintained by Week 40 in participants who first had a clinical response with ICOTROKINRA.
The adolescent part also looks at maintenance and measures clinical remission by Week 40 in adolescents with moderately to severely active ulcerative colitis who first responded to ICOTROKINRA. This means the study is not only checking short-term improvement, but also whether benefit can last in younger participants.
Crohn’s disease study
The Crohn’s disease trial is titled Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease. It is an authorised Phase 4 study with 1,090 participants.
This trial includes a Phase 2b induction part and Phase 3 induction and maintenance parts. The induction parts study whether ICOTROKINRA can help people improve at Week 12, while the maintenance part studies whether that benefit can continue to Week 40.
For Phase 3 induction, the co-primary endpoints are clinical remission and endoscopic response at Week 12. For Phase 3 maintenance, the co-primary endpoints are clinical remission and endoscopic response at Week 40.
Endoscopic response means the bowel looks better on a scope test, which helps show whether inflammation inside the bowel has improved.
Who can participate
The ulcerative colitis study includes adult and adolescent participants with moderately to severely active disease. The Crohn’s disease study includes participants with moderately to severely active Crohn’s disease.
Based on the trial data, the studies are focused on people whose disease is active enough to need research treatment and close follow-up. The source data do not give full details about all entry rules, so the exact participation criteria are not listed here.
What is being measured
The main outcome in the ulcerative colitis study is clinical remission at Week 12 for the adult induction part and at Week 40 for the adult and adolescent maintenance parts. Clinical remission means the disease signs and symptoms are very low or absent.
The Crohn’s disease study measures clinical response in the Phase 2b induction part at Week 12, and clinical remission plus endoscopic response in the Phase 3 induction and maintenance parts. A clinical response means the person improves, even if they do not reach full remission.
These outcomes help researchers understand both symptom improvement and bowel healing over time.
Trial phases and status
The ulcerative colitis study is a Phase 3 trial and is authorised. Phase 3 studies are usually larger studies that help confirm how well a treatment works.
The Crohn’s disease study is a Phase 4 trial and is also authorised. It includes Phase 2b and Phase 3 parts inside the same research program, which allows researchers to study different stages of treatment in one overall trial.
Across both trials, the focus is on whether ICOTROKINRA can help people with active inflammatory bowel disease reach remission or clear improvement and keep that benefit over time.